STIMULEN COLLAGEN— 510(k) K030774

Name: FDA 510(k) clearance K030774
Creator: U.S. Food and Drug Administration
Published: 2004-08-09

Substantially Equivalent

Southwest Technologies, Inc.

FDA 510(k) clearance K030774 for STIMULEN COLLAGEN, Substantially Equivalent on 2004-08-09. Applicant: Southwest Technologies, Inc.. Device class: Unclassified.

Clearance details

Applicant: Southwest Technologies, Inc.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2003-03-11
Decision date: 2004-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGN

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K260652 — ColActive Plus2026-09-09
K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more2026-08-27
K260596 — Collagen Wound Powder2026-07-02
K260669 — Endoform Dermal Template2026-06-24
K253521 — ECMT-100 WMD2026-06-18

More clearances from Southwest Technologies, Inc.

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K102478 — OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING2010-11-03
K083334 — ELASTO-GEL MANUKA HONEY WOUND DRESSING2009-07-30
K872488 — ELASTO-GEL CAST & SPLINT PADS1987-09-21
K872165 — ELASTO-GEL OCCLUSIVE DRESSING1987-06-26

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K030774

K-number listed on FDA's recall record

Z-2109-2021 — Stimulen Collagen Moisturizing Lotion, ST9555BClass II·Ongoing·Southwest Technologies Inc·20210528

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030774.

Data sourced from openFDA. This site is unofficial and independent of the FDA.